{
  "format": "devicerts.device.v1",
  "cite_as": "Nidek Digital Keratometer, Nidek, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/nidek-digital-keratometer-hql (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/nidek-digital-keratometer-hql",
    "json_url": "https://devicerts.com/devices/nidek-digital-keratometer-hql.json",
    "markdown_url": "https://devicerts.com/devices/nidek-digital-keratometer-hql.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "registry_records_last_synced": "2026-10-06",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/nidek-digital-keratometer-hql",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "device": {
    "name": "Nidek Digital Keratometer",
    "registry_name": "NIDEK DIGITAL KERATOMETER",
    "url": "https://devicerts.com/devices/nidek-digital-keratometer-hql",
    "manufacturer": {
      "name": "Nidek, Inc.",
      "url": "https://devicerts.com/manufacturers/nidek-inc",
      "country": "United States",
      "country_basis": "FDA 510(k) applicant",
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class III",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K842892",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "HQL"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Nidek Digital Keratometer is a diagnostic device classified as a keratometer, used to measure the curvature of the cornea. It provides precise readings of corneal radius and refractive power, aiding in the assessment of corneal topography and the fitting of contact lenses or intraocular lenses.\n\nThis device is intended for use in ophthalmic settings and is supplied as a reusable instrument. It requires no sterility beyond standard clinical cleaning protocols and is not intended for MRI environments. The device is authorised under FDA 510(k) clearance (K842892) and falls under regulation number 886.3600. No third-party review was involved in its authorisation.",
      "ai_generated": true,
      "generated_on": "2026-09-18",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K842892",
      "number_label": null,
      "device_udi_di": null,
      "date": "1984-10-05",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K842892",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "HQL",
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            }
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    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class III",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 886.3600",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Ophthalmic",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
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        {
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          "values": [
            {
              "value": "SESE",
              "registries": [
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              ]
            }
          ]
        }
      ]
    }
  ]
}